AB0334 EFFICACY AND SAFETY OF ABATACEPT IN CHINESE PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS: REAL-WORLD DATA
Authors: Y. F. Qing, Q. Huang, Z. Y. Zhao, Q. B. Zhang, L. Q. Li, Z. Wen, Z. X. You, H. Tang, H. Xu
Journal: Annals of the Rheumatic Diseases (2022)

Background Abatacept (ABA) has demonstrated efficacy and safety in active rheumatoid arthritis (RA) patients in Europe and the United States as one of bDMARDs [1]. However, the clinical activity of Abatacept (ABA) has not been sufficiently investigated in patients with RA from a real-world clinical setting in China. Objectives This study was designed to investigate the efficacy and safety of Abatacept in the RA patients in Chinese population who were refractory to csDMARDs, aiming to provide further reference for clinical rational drug use. Methods Clinical data of 55 patients with active RA who were admitted in the Affiliated Hospital of North Sichuan Medical College from June 2020 to June 2021 and did not respond to csDMARDs was retrospectively analyzed. Patients in this study were treated with Abatacept (125 mg by subcutaneous injection once weekly combined with csDMARDs. Changes in clinical manifestations, including DAS28-ESR, CDAI, ACR 20/50/70 at week 12 and 24 from baseline and AEs during 24 weeks were observed and recorded. Results 55 patients (46 women and 9 men) were included in this study with a mean age 50.80 ± 12.46 and a mean disease duration of 6.29 ± 6.22 years. The ACR 20 response at week 12 and 24 was 50.91% (28/55) and 87.27% (48/55), respectively. Besides, DAS 28-ESR score were significantly lower at week 12 and 24 compared to baseline (P &lt;0.05) with 19 patients (34.55%) achieving clinical remission or low disease activity. Changes in CDAI scores revealed that 80% patients achieved clinical remission or low disease activity at week 24. DAS28-ESR score was significantly lower in previously untreated patients (Biologic-naive) (n=36) (3.40 ± 0.81) than in the previously treated patients (Biologic non-naive) (n=19) (3.83 ± 0.68) (P = 0.02) (Figure 1). RF, CCP antibody and GLOB levels were significantlyreduced in RA patients after 24-week ABA treatment compared to baseline ( P ﹤0.05) (Table 1). Two hepatitis B virus (HBV) carriers, two patients with active tuberculosis and one patient with latent tuberculosis status showed no reactivation of HBV and no new active tuberculosis lesions 24 weeks after treatment with ABA. AEs were reported in 9.1% (5/55), but no serious infections occurred. Table 1. Analysis of clinical and serological parameters at baseline and after treatment with Abatacept. Indexes Baseline 12 weeks 24 weeks TJC 6 (4，10) 3 (2，4) * 2 (1，3) ** SJC 2 (1，4) 1 (0，2) * 0 (0，1) ** PtGA-VAS（0-10cm） 8 (7，10) 5 (3，6) * 2（2，3） ** HAQ 2 (0，4) 1 (0，2) * 0 (0，1) ** ESR （mm/h） 51 (41，89) 37 (28，51) * 23 (17，37) ** HsCRP（mg/L） 14.08 (3.7，35.0) 5，77 (2.27，20.78) * 4.12 (1.34，9.37) ** GLOB 34.47±5.69 - 30.33±3.81 * RF-IgM (IU/mL) 408.55 (68.8,566.5) - 167.41 (34.9, 171.25) * RF-IgG (U/mL) 8.63 (4.55, 11.1) - 7.94 (3.13, 6.23) * RF-IgA (U/mL) 90.18 (25.63, 99.12) - 58.20 (16.81, 59.09) * CCP (RU/mL) 1095.45 (66.79, 1033.28) - 782.0 (58.49, 857.5) * * p ﹤0.05,TJC=Tender joint count, SJC=Swollen joint count, GLOB= immunoglobulin. Conclusion In the Chinese patients with active RA refractory to csDMARDs, the combination of ABA and csDMARDs showed great clinical efficacy and a favorable safety profile. Moreover, ABA resulted in better efficacy in patients previously untreated with biologics than previously treated with biologics. References [1]Weinblatt ME, Schiff M, Valente R,et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum 2013; 65:28-38. Disclosure of Interests None declared